arthrex eclipse™ shoulder prosthesis

Conditions: Osteoarthritis

Summary: a prospective, randomized, multicenter study comparing the safety and effectiveness of arthrex's eclipse™ shoulder to the univers™ ii shoulder prosthesis in patients with a degenerative joint disease.

the purpose of this study is to demonstrate non-inferiority of the arthrex eclipse™ shoulder prosthesis to the arthrex univers™ ii shoulder prosthesis for the treatment of degenerative joint disease in subjects who are candidates for total shoulder replacement. non-inferiority in terms of safety and effectiveness will be measured by a 2 year composite clinical success (ccs) that requires functional improvement, radiographic success, absence of reoperations and revision, and lack of serious device-related adverse events.

Eligibility criteria:
inclusion criteria: * the subject is \> 21 years of age * the subject has continued symptoms in target shoulder despite at least 3 months of other treatment modalities(e.g.: anti-inflammatory, physical therapy and steroid injections) * the subject has a diagnosis in the target shoulder of one or more of the following: osteoarthritis, avascular necrosis, post-traumatic arthritis, or rheumatoid arthritis. * the subject presents with pain and functional impairment in the index shoulder, measured by an adjusted constant score of ≤50. note: the adjusted constant score will be calculated from the raw constant score to establish patient eligibility. * the subject is willing to receive implantation of the arthrex™ shoulder prosthesis or univers™ ii shoulder prosthesis. * the subject must be physically and mentally willing and able to comply with all study procedures (including follow-up visits and radiographic assessments) until the conclusion of the study. * the subject has been informed of the nature of the study and provided written consent as approved by the sites local institutional review board or ethic review board. exclusion criteria: * the subject is likely a candidate for hemi-humeral arthroplasty (i.e.: avascular necrosis of the humeral head without glenoid involvement (stages 0-3): rotator cuff deficient shoulder: glenoid bone deficiency/deformity that precludes glenoid replacement (walch type b2 or c) or fractures of the proximal humerus, without glenoid involvement. * the subject has immature bone as defined by the absence of cancellous bone patterning, a mature, thick cortex, and stress lines within the cancellous bone. * the subject has obvious defects in bone quality, such as cysts or lesions, in the humeral head of the target shoulder, as demonstrated by radiographic evaluation. * the subject has a target shoulder a rotator cuff that is not intact and not reconstructible. * the subject has irreducible 3- and 4- part proximal humeral fractures of the target shoulder. * the subject has documented history of foreign-body sensitivity. * subject with positive pregnancy test, or lactating, or intends to become pregnant during treatment period * the subject has history of schizophrenia, bipolar disorder and/or major depressive disorder as defined by dsm iv. * the subject is skeletally immature demonstrated radiographically by incomplete closure of proximal humeral epiphyses. * the subject is at high risk for poor healing or confounding outcomes \[(i.e.: clinically significant renal, hepatic, cardiac hematologic disease or endocrine disease)\] * the subject is on immune-stimulating or immunosuppressive agents * the subject has co-morbidity that reduces life expectancy \< 36 month. * the subject seeking or receiving workman's compensation for shoulder injury, * the subject is \> 350 lbs. * the subject engaged in heavy labor (e.g. repetitive lifting in the excess of more than 50 lbs.) * the subject has had surgery in the affected shoulder in the last 12 months (with the exception of diagnostic arthroscopy without reconstruction or repair procedures) * the subject is engaged in active sports participation. (e.g. weight lifting involving upper extremities or involved in contact sports) * the subject is taking medications known to potentially interfere with bone/soft tissue healing (e.g. steroids with the exception of topical and/or inhalers) * the subject is a prisoners or wards of the state * the subject has a history of alcohol and/or substance abuse as defined by dsm iv (diagnostic and statistical manual diploma in social medicine) * the subject has an active or chronic infection, either systemic or local. * the subject has pathologic fractures of the affected shoulder * the subject has acute trauma of the affected shoulder * the subject has osteoporosis defined as a bone density t score of \< or = -2.5. (a screening questionnaire for osteoporosis, score (simple calculated osteoporosis risk estimation) and mores (male osteoporosis risk estimation score), will be used to screen patients who require a dexa (dual energy x-ray absorptiometry) bone mineral density measurement.